The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT01863641|
Recruitment Status : Unknown
Verified May 2013 by Alireza Amir Maafi, Guilan University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: calcitriol Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Calcitriol on Progress and Activity of Lupus Nephritis|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||April 2014|
Experimental: treatment group
Patients will receive calcitriol at a fixed dose daily.
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
Active Comparator: control group
Patients will receive placebo daily.
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
- change in proteinuria [ Time Frame: baseline and 12 months ]
- risk of lupus flare [ Time Frame: baseline and 12 months ]
- change in renal function [ Time Frame: baseline and 12 months ]based on the American College of Rheumatology renal response criteria
- change in serum inflammatory markers [ Time Frame: baseline and 12 months ]
- change in Systemic Lupus Erythematosus Disease Activity Index score [ Time Frame: baseline and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863641
|Contact: Alireza Amir Maafi, MD Studentemail@example.com|
|Iran, Islamic Republic of|
|Rasht, Guilan, Iran, Islamic Republic of|
|Contact: Alireza Amir Maafi, MD Student 00989376036481 firstname.lastname@example.org|
|Study Chair:||Banafsheh ghavidel parsa, MD||Guilan University of Medical Sciences, Iran|
|Principal Investigator:||Alireza Amir Maafi, MD Student||Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran|